Validation Engineer

Role summary / purpose

We are seeking a Validation Engineer to join our team in Greenville, South Carolina. In this role, you will lead design qualification and validation efforts for medical device equipment and pharmaceutical packaging systems, ensuring compliance with FDA regulations and industry standards. You will author critical documentation, develop validation strategies, and collaborate with internal and customer teams throughout the equipment lifecycle.

Key responsibilities

Requirements and Design Documentation

• Review and interpret customer URS documents, identifying gaps, ambiguities, and testability concerns early in the project.
• Create Functional Design Specifications (FDS) and Vision Design Specifications (VDS) that trace back to customer requirements.
• Organize, guide, and write additional requirement and design specifications as needed.
• Develop and maintain requirements traceability matrices linking URS, design specifications, and test protocols.

Validation Planning and Protocols

• Write overall project quality and validation plans that define scope, deliverables, responsibilities, and acceptance criteria.
• Develop document templates tailored to each customer''s SOPs and documentation standards.
• Organize, guide, and write qualification plans and protocols, including FAT, SAT, IQ, and OQ.
• Participate in or lead risk assessments (e.g., FMEA) to establish a risk-based testing approach.

Execution and Reporting

• Oversee and execute validation qualifications at our facility and at customer sites.
• Review qualification and requalification packages for completeness, accuracy, sound rationale, and compliance with validation policies.
• Document and help resolve deviations, discrepancies, and change requests, identifying any qualification impact to maintain the system''s validated state.
• Create validation summary reports and support final turnover documentation packages.

Collaboration and Quality Leadership

• Provide validation guidance throughout equipment design, software design, build, debug, and qualification phases.
• Interface with internal and customer validation and engineering teams to secure document reviews and approvals.
• Drive a quality-focused approach across the organization, including change control and documentation practices for equipment design, software, and project records.
• Support all aspects of the validation lifecycle, from design through operation and continuous improvement.

Requirements - education & experience

• Bachelor''s degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of validation experience in an FDA-regulated environment (pharmaceutical, medical device, biotech, or equipment supplier/integrator).
• Demonstrated experience authoring URS, FDS, and design specifications, as well as IQ/OQ protocols and summary reports.
• Working knowledge of applicable regulations and guidance, including 21 CFR Part 11, 21 CFR Parts 210/211 and/or Part 820, and ISPE GAMP 5.
• Understanding of computer system validation (CSV) and data integrity principles (ALCOA+).

Required skills

• Strong technical writing skills with exceptional attention to detail.
• Ability to communicate confidently with customers and work across engineering disciplines.
• Design Qualification experience with medical device equipment or secondary and tertiary packages for pharmaceutical or food products.
• Willingness to travel to customer sites for FAT/SAT and on-site qualification activities.

Nice-to-have / preferred skills

• Experience with custom automation equipment, machine builders, or system integrators.
• Familiarity with automated control systems such as PLCs, HMIs, SCADA, vision systems, robotics, and serialization equipment.
• Experience with Computer Software Assurance (CSA) and risk-based validation approaches.
• Knowledge of EU GMP Annex 11, ISO 13485, and ISO 14971.
• Experience with electronic validation or document management systems (e.g., Kneat, ValGenesis, MasterControl).

Employment details - type, location, hours

Location: Greenville, South Carolina